Vinorelbine

What is Vinorelbine?

• Vinorelbine (Navelbine) is a vinca alkaloid used alone or with cisplatin to treat non-small cell lung cancer that is locally advanced or has spread to other parts of the body.
• It is also being studied in the treatment of other types of cancer.

Vinorelbine

Vinorelbine ball-and-stick

Vinorelbine2DACS

What are the uses of this medicine?

Vinorelbine (Navelbine) is approved to treat:

• Non-small cell lung cancer

It is used as first-line therapy:

• With cisplatin in patients with locally advanced disease.
• Alone or with cisplatin in patients whose disease has metastasized (spread to other parts of the body).

How does this medicine work?

• The vinca alkaloids are antineoplastic agents that act by binding to intracellular tubulin, the basic protein subunit of microtubules which are important in many intracellular processes including mitosis and cell division.
• The vinca alkaloids inhibit cell division by blocking mitosis; they also inhibit purine and RNA synthesis causing death of rapidly dividing cells.
• Vincristine and vinblastine were initially isolated from periwinkle (vinca rosea), extracts of which were found to have antitumor activity. Subsequently, they have been synthesized, although their structure is quite complex.
• Vinorelbine is a semisynthetic derivative of extracts of periwinkle.
• Vincristine (vin kris' teen) was approved for use in cancer chemotherapy in 1963, vinblastine (vin blas' teen) in 1965 and vinrelbine (vin or' el been) in 1994.
• They have become major components of many combination anticancer regimens, used particularly in treatment of acute leukemia, Hodgkin disease and other lymphomas, various sarcomas, Wilms tumor, neuroblastoma, and breast and lung cancer.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• certain antifungals such as itraconazole (Onmel, Sporanox, Tolsura) and ketoconazole
• clarithromycin
• HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, Technivie, Viekira), and saquinavir (Invirase)
• nefazodone

Is this medicine FDA approved?

• Vinorelbine was approved for medical use in the United States in 1994.

How should this medicine be used?

Recommended dosage: In Combination with Cisplatin 100 mg/m2:

• The recommended dosage of Vinorelbine Injection is 25 mg/m2 administered as an intravenous injection or infusion over 6 to 10 minutes on Days 1, 8, 15 and 22 of a 28-day cycle in combination with cisplatin 100 mg/m2 on Day 1 only of each 28-day cycle.

In Combination with Cisplatin 120 mg/m2:

• The recommended dosage of Vinorelbine Injection is 30 mg/m2 administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m2 on Days 1 and 29, then every 6 weeks.

Single Agent:

• The recommended dosage of Vinorelbine Injection is 30 mg/m2 administered intravenously over 6 to 10 minutes once a week.

Administration:

• Vinorelbine comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a medical facility.
• It is usually given once a week.
• The length of treatment depends on how well your body responds to treatment with vinorelbine.
• You should know that vinorelbine should be administered only into a vein.
• However, it may leak into surrounding tissue causing severe irritation or damage.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Vinorelbine Injection: 10 mg per 1 mL and 50 mg per 5 mL in single-dose vial

This medicine is available in fallowing brand namesː

• Navelbine

What side effects can this medication cause?

The most common side effects of this medicine include:

• leukopenia
• neutropenia
• anemia
• increased aspartate aminotransferase
• nausea
• vomiting
• constipation
• asthenia
• injection site reaction
• peripheral neuropathy

What special precautions should I follow?

• Myelosuppression, manifested by neutropenia, anemia and thrombocytopenia, occur in patients receiving vinorelbine as a single agent and in combination with cisplatin. Monitor complete blood counts prior to each dose of vinorelbine. Do not administer vinorelbine to patients with neutrophil counts <1,000 cells/mm3. Adjustments in the dosage of vinorelbine should be based on neutrophil counts obtained on the day of treatment.
• Drug-induced liver injury manifest by elevated aspartate aminotransferase (AST) and bilirubin occur in patients receiving vinorelbine as a single agent and in combination with cytotoxic agents. Reduce the dose of vinorelbine for patients who develop elevations in total bilirubin ≥ 2 times upper limit of normal.
• Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation occur in patients receiving vinorelbine.
• Extravasation of vinorelbine can result in severe irritation, local tissue necrosis and/or thrombophlebitis. If signs or symptoms of extravasation occur, immediately stop administration of vinorelbine and institute recommended management procedures.
• Sensory and motor neuropathies, including severe neuropathies, occur in patients receiving vinorelbine. Discontinue vinorelbine for CTCAE Grade 2 or greater neuropathy.
• Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome (ARDS) occur in patients receiving vinorelbine. Permanently discontinue vinorelbine for confirmed interstitial pneumonitis or ARDS.
• Based on findings from animal studies and its mechanism of action, vinorelbine can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception.
• Advise women not to breastfeed during treatment with Vinorelbine Injection and for 9 days after the final dose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• sores in the mouth and throat
• stomach pain
• constipation
• fever, sore throat, chills, or other signs of infection
• loss of the ability to move muscles and to feel a part of the body
• paralytic ileus
• stomatitis
• esophagitis
• Bone marrow aplasia
• sepsis
• paresis

Management of overdosage:

• There is no known antidote for overdoses of vinorelbine.
• If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors and antibiotics should be instituted as deemed necessary by the physician.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, vinorelbine can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of vinorelbine in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• vinorelbine tartrate

Inactive ingredients:

• water

Who manufactures and distributes this medicine?

Mfd. for SAGENT Pharmaceuticals

• Schaumburg, IL (USA)
• Made in China
• Sagent Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store refrigerated between 2° and 8°C (36° and 46°F).
• Do not freeze.
• Protect from light.
• Retain in carton until time of use.
• Discard unused portion.
• Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours.
• Store diluted solutions of Vinorelbine Injection, USP at 5° to 30°C (41° to 86°F).
• Vinorelbine Injection, USP is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

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• Dailymed label info on Vinorelbine
• FDA Vinorelbine

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